{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198186", "product_res_number": "Z-1160-2023", "event_date_initiated": "2023-01-05", "event_date_posted": "2023-02-22", "recall_status": "Open, Classified", "res_event_number": "91562", "product_code": "CAH", "k_numbers": [ "K192713" ], "product_description": "abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087\n\nabm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088\n\nabm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273\n\nabm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089", "code_info": "Product Code: BC21087\nLot Number: SM6002.2207.12\n\nProduct Code: BC21088\nLot Number: SM6003.2507.12\n\nProduct Code: BC21273\nLot Number: SM6001.2207.12\n\nProduct Code: BC21089\nLot Number: SM6004.2607.12", "firm_fei_number": "3020777588", "recalling_firm": "S & MOHR AMERICA, S.A. DE C.V.", "address_1": "Circuito De La Industria Poniente Lote 10 C", "city": "Estado", "state": "De Mexico", "country": "Mexico", "reason_for_recall": "Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is \"22.07.2027\"", "root_cause_description": "Process control", "action": "On or about 01/10/2023, the firm emailed a Customer Notification to customers notifying them that specific lots of Breathing Circuits were incorrectly label with the manufacturing dated as the expiration date for the product. The correct expiration dates range from 07/22/2027 to 07/26/2027 (5 year shelf-life).\n\nCustomers are informed that the affected products can be used without risk to the patient up and until July 2027.\n\nFor questions, contact Quality Assurance Department at +905426624107 Monday through Friday between 8:00 a.m. to 5:00 p.m. EST", "product_quantity": "1,320 masks", "distribution_pattern": "U.S. Nationwide distribution in the state of MN.", "openfda": { "k_number": [ "K190022", "K032716", "K934132", "K945543", "K851070", "K954490", "K760567", "K132709", "K912577", "K952015", "K965016", "K770376", "K801803", "K221472", "K110246", "K011212", "K222917", "K772047", "K925462", "K934189", "K922492", "K862786", "K182862", "K013122", "K830618", "K781696", "K980662", "K812075", "K941536", "K021020", "K880958", "K952428", "K043148", "K925388", "K111408", "K896832", "K900990", "K890346", "K883693", "K923661", "K931217", "K896116", "K221250", "K000654", "K230483", "K890035", "K002201", "K092218", 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